FDA Recall
Open, Classified
Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle screw systems.
Recall: Z-1620-2024
·
Initiated February 28, 2024
Recall
- Recall Number
- Z-1620-2024
- Event Number
- 94306
- Firm
- SEASPINE ORTHOPEDICS CORPORATION
- FEI Number
- 3012120772
- Product Code
- NKB
- Status
- Open, Classified
- Root Cause
- Nonconforming Material/Component
- Initiated
- February 28, 2024
- Posted
- April 23, 2024
- Address
- 5770 Armada Dr, Carlsbad, CA, 92008-4608
Description
Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle screw systems.
Reason
Screw heads, of pedicle screw systems, have partial thread within the screw head that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.
Action
On 2/26/24, the firm phoned customers and informed them of the recall and that they would receive an email outlining details of the field action and subsequent steps to be taken. On 2/28/24, recall emails were sent to customers asking customers to respond to the emails to coordinate product return and replacement. Customers with questions can contact the firm at [email protected].
Distribution
US: CA, FL, CO, TX
Quantity
444 Screw Heads